Randomization and blinding Randomization of treatment allocation largely ensures unbiased treatment comparison. A simple randomization scheme for treatment allocation will be done using a table of random numbers by a Statistician/ Epidemiologist not associated with conduct of the study. He/she will label the boxes of treatment with individual patient numbers from 1-200 according to the randomization scheme. This person will keep the assignment code at a safe place; the code will be available to the investigator only at the end of the trial. These will be serially opened as new patients are recruited into the study. Double blinding will be done to ensure minimum bias i.e. blinding of researcher and clinician attending patients to the randomization process so that allocation and outcome evaluation are not affected and blinding of patients to the identity of the drug or intervention they are receiving. The inert placebo, which will be identical to the active drug in packaging, appearance and schedule of administration.